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Vaccine Advances Drive Differentiation

Seasonal and Pandemic Vaccines

The seasonal influenza market is dominated by well-established pharma companies that have approximately 10% of the total market each, according to Ramya Kartikeyan, Ph.D., head of infectious diseases for market analyst GlobalData. “Vaccines have been a prophylactic option for years, which makes the space somewhat more mature than some other infectious disease indications, like HIV,” she said.

Globally, the major prophylactic vaccines providers are Sanofi, GSK, AstraZeneca (MedImmune), Novartis, and CSL Biotherapies, Dr. Kartikeyan reported. A few small, indigenous players are also present. “However,” she added, “new players are poised to enter this competitive space with new vaccines, such as those using recombinant DNA technology.

“The main innovations in this space currently are the development of quadrivalent vaccines, new manufacturing methods, new routes of administration and adjuvants that elicit stronger responses,” Dr. Kartikeyan said.

Quadrivalent Vaccines

GSK and AstraZeneca already have approval and will introduce quadrivalent influenza vaccines in the U.S. and/or European marketplace within the next two years, Dr. Kartikeyan reported. When that occurs, they are expected to usurp trivalent vaccines, which currently account for annual global sales of $2.3 billion. By 2012, annual global sales are expected to approach $3 billion.

As Dr. Kartikeyan explained, adding an extra type B strain to trivalent vaccines increases protection for children, who are more susceptible than adults to type B strains. It also helps health authorities hedge their bets when selecting strains for seasonal vaccines. “It’s a step in the right direction,” Dr. Kartikeyan said, as the industry works toward universal influenza vaccines.

Market Differentiation

“These days, product differentiation is mostly set around offering immunity to at-risk populations or eliciting a stronger immune response through different routes of administration or adjuvants,” Dr. Kartikeyan explained.

“Innovative technology platforms that produce thermostabile, needle-less vaccines using microinjections and antigen-sparing adjuvants are likely to have a major impact on a company’s growth and market position,” Frost & Sullivan’s Chidambaram added.

Consequently, vaccines like AstraZeneca’s intranasal FluMist® and Sanofi’s intradermal Fluzone®, are projected to see rapid adoption. As Dr. Brad Tebbets, analyst, infectious diseases, GlobalData, elaborated, “AstraZeneca has established FluMist as the vaccine of choice for children over two years of age in the U.S. It launched in Europe last year as Fluenz, and received a U.K. contract for a mass vaccination program for two to 17-year-olds. That contract is set to begin in 2014.”

Nontraditional Manufacturing

In January, Protein Science’s FluBlok® became the world’s first recombinant influenza vaccine, developed using insect cell culture. Currently approved for people between 18 and 49 years old, approval for all persons 18 and older is expected later this year. Limited supplies are available now, with full availability anticipated for the 2013/2014 flu season.

Novavax has taken another approach, combining insect cell culture and recombinant baculovirus protein nanoparticles, to produce influenza vaccine candidates. The company is targeting seasonal and pandemic flu, as well as respiratory syncytial virus, SARS, malaria, and rabies.

Astellas is in late-stage clinical trials for its recombinant H5N1 influenza vaccine, ASP7373. The vaccine is being produced by cell culture, using the baculovirus expression vector system developed at the University of Minnesota.

In November 2012, Novartis’ Flucelvax® became the first mammalian cell-based flu vaccine approved by the FDA. GSK, Astellas, Sanofi, Baxter International, and AstraZeneca also are developing nontraditional manufacturing methods.

As next-generation vaccines mature, Chidambaram said, “they are likely to provide huge cost-savings and therapeutic benefits, and can significantly reduce vaccine development time.”

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